Migraine HeadacheNCT02179775
Effect of "Sekanjabin e Safarjali" (Quince Oxymel) in the Prevention of Migraine Attacks
A study testing propranolol and Quince's oxymel in people with Migraine Headache and Gastric Diseases, run by Shiraz University of Medical Sciences at 2 sites in Iran.
Trial summary
The purpose of this study is to determine whether Quince Oxymel is effective in the prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine Headache, Gastric Diseases
- What is being tested?
- propranolol and Quince's oxymel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesIran
- Study dates
- Jul 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum age of 18 years old
- giving a written informed consent
- having at least 2 migraine attacks per month
Who cannot join
- patients older than 70 years old
- patients with Diabetes mellitus
- patients with chronic obstructive pulmonary disease and asthma
- pregnancy
- severe depression
- patients affected by sexual disorders
- bradyarrhythmic patients
- positive history of hypersensitivity reactions to quince, ginger, propranolol or naproxen
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Shiraz University of Medical Sciences
Shiraz, Fars, +98711
Shariat, MD, shariat123@gmail.com
Abdolhamid Shariat, MD
- Recruiting
Shiraz University of Medical Sciences
Shiraz, Fars, +98711
Hashempur, MD, PhD, hashempur@gmail.com
Mohammad H Hashempur, MD,PhD
About this study
Official title: Comparison of Effectiveness of "Sekanjabin e Safarjali" (Quince Oxymel), Propranolol and Placebo in the Prevention of Migraine Attacks in Patients With Simultaneous Upper Gastrointestinal Dysfunction
The purpose of this study is to determine whether Quince Oxymel is effective in the prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.
Read the detailed description
This is a randomized, placebo-controlled, triple blinded clinical study to evaluate the effects of oral use of "Sekanjebin e Safarjali" (Quince Oxymel) in the Prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.45 patients with Migraine headache aged between 15-70, after taking signed informed consent, according to the International headache society criteria for headache [2] are included in this trial. 45 cases with Migraine headache with simultaneous upper gastrointestinal dysfunction will allocate to three arms by using simple randomization. Quince Oxymel, propranolol and placebo will be given as encoded, innominate bottles with the same shape and color. Quince oxymel and placebo will be prescribed as 10 cc, three times a day for 4 weeks. Frequency, duration and intensity of Migraine Attacks at the beginning time and during 4 weeks of trial, will be evaluated, as the primary outcome measures.
- Conditions
- Migraine Headache, Gastric Diseases
- Being tested
- propranolol, Quince's oxymel, placebo
- Medical subject headings
- Migraine Disorders, Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
Quince's oxymelDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| propranolol | Active comparator | Not described Receives: Drug: propranolol |
| Quince's oxymel | Active comparator | Not described Receives: Drug: Quince's oxymel |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of headache attacks
Measured: 4 weeks
duration of headache attacks
Measured: 4 weeks
Pain Scores as assessed by the Visual Analog Scale
Measured: 4 weeks
Secondary outcomes (1)
self-reported improvement of upper gastrointestinal symptoms (by percent)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hashem Hashempur, Shiraz University of Medical Sciences
- Investigators
- Abdolhamid Shariat, MD, Assistant Professor, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179775
- Sponsor's protocol ID
- 90-01-64-3456
- Status last verified
- Jul 2014
- First submitted
- 27 Jun 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of "Sekanjabin e Safarjali" (Quince Oxymel), Propranolol and Placebo in the Prevention of Migraine Attacks in Patients With Simultaneous Upper Gastrointestinal Dysfunction
- ClinicalTrials.gov ID
- NCT02179775
- Acronym / sponsor ID
- 90-01-64-3456
- Conditions
- Migraine Headache, Gastric Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Quince Oxymel is effective in the prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.
Detailed description
This is a randomized, placebo-controlled, triple blinded clinical study to evaluate the effects of oral use of "Sekanjebin e Safarjali" (Quince Oxymel) in the Prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.45 patients with Migraine headache aged between 15-70, after taking signed informed consent, according to the International headache society criteria for headache [2] are included in this trial. 45 cases with Migraine headache with simultaneous upper gastrointestinal dysfunction will allocate to three arms by using simple randomization. Quince Oxymel, propranolol and placebo will be given as encoded, innominate bottles with the same shape and color. Quince oxymel and placebo will be prescribed as 10 cc, three times a day for 4 weeks. Frequency, duration and intensity of Migraine Attacks at the beginning time and during 4 weeks of trial, will be evaluated, as the primary outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propranolol | Active comparator | Drug: propranolol |
| Quince's oxymel | Active comparator | Drug: Quince's oxymel |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- minimum age of 18 years old
- giving a written informed consent
- having at least 2 migraine attacks per month
Key exclusion criteria (8 listed)
- patients older than 70 years old
- patients with Diabetes mellitus
- patients with chronic obstructive pulmonary disease and asthma
- pregnancy
- severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propranolol | Drug | propranolol |
| Quince's oxymel | Drug | Quince's oxymel |
| placebo | Drug | placebo |
Primary outcome
frequency of headache attacks
Time frame: 4 weeks
duration of headache attacks
Time frame: 4 weeks
Pain Scores as assessed by the Visual Analog Scale
Time frame: 4 weeks
1 secondary outcome
self-reported improvement of upper gastrointestinal symptoms (by percent)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdolhamid Shariat, MD, Assistant Professor principal investigator
Shiraz University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propranolol and Quince's oxymel in people with Migraine Headache and Gastric Diseases, run by Shiraz University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of headache attacks (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.